Processing Supervisor - MTF Biologics

Edison, NJ

About the Job

Overview/Risks

The Processing Supervisor is responsible for directing all activities related to Processing in a controlled and regulated medical device environment. This position requires the Supervisor to work closely with Management and Team Leaders to assign processing resources to meet production demands in an ISO (International Organization for Standardization) certified cleanroom. This position requires the Supervisor to work cross functionally with multiple departments to manage and support the process. The Supervisor will oversee daily operational activities through key performance indicators to monitor process performance. The Supervisor will actively manage the team inside the core processing areas and ensure adherence to the Standard Operating Procedures (SOP�??s), corporate Policy and MTF Quality Standards. The Supervisor will work closely with the training team to develop employee competencies needed for flexibility, responsiveness and employee growth.

Responsibilities

Actively manage his/her team in the controlled environments and develop team members and promote teamwork, collaboration and continuous improvement. This is done through one-on-ones, team meetings and by spending time in the cleanroom and controlled environments working with team members.

Manage payroll and ensure overtime is in line with budget.

Maintain direct report PTO (paid time off) approvals.

Meet with employees on a routine basis. Promote job enrichment and goal obtainment.

Perform observations to ensure adherence to procedure and policy. Maintain safety standards and ensure that safe and quality tissue is processed. Monitor and support organization of the cleanroom environment.

Interview, hire and assist with new employee development and training. Conduct team meetings to keep the processing team well informed of current goals and any relative information and to promote a teamwork environment.

Work with the Associate Manager/Manager to balance production requirements in regards to labor and facility/equipment capacity in relation to current and future demand.

Monitor department’s metrics such as Production, Inventory, Goals, Quality, Safety, and Errors.

Perform annual evaluations of direct reports and complete merit and bonus activities.

Adhere to the Progressive Discipline Policy while enforcing Processing departmental guidelines.

Work with the Trainer to ensure the processing technicians are informed and trained in regards to processing related NCR’s, complaints, and errors. Work with the Training department to ensure team members are competent.

Work closely with their Manager/Associate Manager to meet business needs.

Maintain working knowledge of the processes he/she is responsible for. Work with a wide range of equipment and chemicals such as cutting tools, measuring tools, Spor- klenz, bleach, and Ethanol in an ISO controlled environment.

Required to work weekends and/or off hours when necessary to meet organizational needs. This includes preparation for both bi-annual and weekend shutdowns of cleanrooms and work closely with the Facilities department to make appropriate preparations.

May provide back-up support in the absence of another Supervisor or Team Leader.

May perform process activities in times of need. Work with potential biological hazardous waste and materials.

Assist with special projects and perform additional duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS

Education: High School Diploma/GED

Years of Experience: 4 - 6 years

Other: 4 - 6 years’ experience in one of the following: tissue banking, supervision, surgical technician, nursing or related medical technology background, medical device or pharmaceutical manufacturing or production type environments, ISO class 8 or less clean room / controlled environment.

Specialized Knowledge, Technical Skills, and Abilities:

Strong interpersonal skills coupled with strong leadership abilities.
Must have the ability to work cross functionally in a compliant structure while fostering a collaborative and continuous learning environment.
Proficiency with Microsoft Office
Ability to work independently and in a team environment.
Demonstrated ability to organize work of self and others.

PREFERRED QUALIFICATIONS

Education: College Coursework in science, business or relevant field or College degree – Business, Science or relevant field.

Years of Experience: Other

Other: 5-7 years’ experience in one of the following: tissue banking, supervision, surgical technician, nursing or related medical technology background, medical device or pharmaceutical manufacturing or production type environments, ISO class 8 or less clean room / controlled environment.

Specific Licenses and/or Certifications: Other

Other: Training in: Lean 6 Sigma and/or Lean Manufacturing

Specialized Knowledge, Technical Skills, and Abilities:

Current Good Manufacturing Practices (cGMP’s – FDA Code of Regulations 21 CFR Part 210 & 211),
Quality System Regulations (QSR’s – FDA Code of Federal Regulations 21 CFR Part 820).
Current Good Tissue Practices (cGTP’s – FDA Code of Federal Regulations - 21 CFR Part 1271).
Work environment - ISO 14644-1 Classification 4 – 8, Federal Standard 209E - Class 10 – 100,000

Source : MTF Biologics